Orange Book product · Generic (ANDA)
METHYLENE BLUE
METHYLENE BLUE
At a glance
Jul 30, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 30, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLENE BLUE
Strength
50MG/10ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 219363
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METHYLENE BLUE
- 2019PROVAYBLUEBrand (NDA)
NDA 204630 · PROVEPHARM SAS
- 2026METHYLENE BLUEGeneric (ANDA)
ANDA 215636 · ZYDUS LIFESCIENCES
- 2025METHYLENE BLUEGeneric (ANDA)
ANDA 219550 · CHENGDU SHUODE
- 2025METHYLENE BLUEGeneric (ANDA)
ANDA 217380 · MEITHEAL
- 2024METHYLENE BLUEGeneric (ANDA)
ANDA 216959 · HIKMA
- 2024METHYLENE BLUEGeneric (ANDA)
ANDA 216955 · STERISCIENCE
- 2024METHYLENE BLUEGeneric (ANDA)
ANDA 217561 · NEXUS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
